MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. TRANSPAC® IV MONITORING KIT

Model Number 42632-05

Device Problem Detachment Of Device Component (1104)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/23/2017

Event Type  malfunction  

Manufacturer Narrative

The device is expected to be returned to the manufacturer for investigation.It has not yet been received.

Event Description

The event involved a customer report of a transpac iv monitoring kit that disconnected at the connection of the device.It was reported that there was suspicion of missing solvent to glue it properly.No adverse patient consequences reported.

Manufacturer Narrative

One (1) used 'partial set', transpac iv mgt.Kit was received for evaluation with no tubing separation.The kit was primed and pressure tested.During priming, a leak was observed between the male luer and the 60" administration tubing.The administration tubing was found to separate during handling of the product, confirming a separation between the administration tubing and the male luer.This was caused by insufficient solvent around the tubing.

• Brand Name: TRANSPAC® IV MONITORING KIT
• Type of Device: TRANSPAC® IV MONITORING KIT
• Manufacturer (Section D): ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.; avenida cuarzo no. 250; colonia rancho santa clara, ma; ensenada, 22790 ; MX 22790
• MDR Report Key: 7161807
• MDR Text Key: 96822706
• Report Number: 9617594-2018-00002
• Device Sequence Number: 1
• Product Code: DRS
• UDI-Device Identifier: 00840619033811
• UDI-Public: 840619033811
• Combination Product (y/n): N
• PMA/PMN Number: K061573
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 01/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 42632-05
• Device Catalogue Number: 42632-05
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/11/2018
• Patient Sequence Number: 1